October 12, 2018 — The Council on Radionuclides and Radiopharmaceuticals Inc. (CORAR) — the voice of the radionuclide, radiopharmaceutical and nuclear pharmacy industries in North America — strongly supports legislation recently introduced by Congressman George Holding (R-NC-2) and Seth Moulton (D-MA-6). This legislation, designated H.R. 6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018, would direct the Secretary of Health and Human Services to recognize diagnostic radiopharmaceuticals (RPs) as drugs and institute a separate payment policy under the Medicare Hospital Outpatient Prospective Payment System (OPPS).
According to the Society of Nuclear Medicine and Molecular Imaging (SNMMI), more than 20 million Americans benefit each year from nuclear medicine procedures.1 Diagnostic RPs are drugs necessary for all nuclear medicine imaging studies to diagnose and determine the severity of disease. Nuclear medicine imaging procedures are effectively used in the diagnosis and treatment of disease states such as cardiovascular disease, some forms of cancer, Parkinson’s Disease, thyroid disease and epilepsy.
Diagnostic and therapeutic RPs are statutorily considered drugs and are regulated as drugs by the Food and Drug Administration. However, since 2009 diagnostic RPs under the OPPS have been packaged with the procedure into Ambulatory Payment Classifications (APCs) for a bundled payment to hospitals while therapeutic RPs continue to be paid separately. Diagnostic RP costs may vary widely within a nuclear medicine APC with some diagnostic RP costs significantly exceeding the APC payment rate.
The Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 will ensure that diagnostic RPs are recognized as drugs and that all diagnostic RPs are appropriately paid under the OPPS. This will safeguard patient access to newer precision diagnostic RPs and support more innovation to improve clinical outcomes and deliver more cost-effective care, according to CORAR.
For more information: www.corar.org
Reference
- Society of Nuclear Medicine and Molecular Imaging, http://www.snmmi.org/ClinicalPractice/content.aspx?ItemNumber=4825
August 03, 2023 
